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Future Medicine, Immunotherapy, 8(14), p. 609-616, 2022

DOI: 10.2217/imt-2021-0336

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Long-term safety of facilitated subcutaneous immunoglobulin treatment in pregnant women with primary immunodeficiency diseases: results from a registry study

This paper is made freely available by the publisher.
This paper is made freely available by the publisher.

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Data provided by SHERPA/RoMEO

Abstract

Aim: Clinical outcomes of women who become pregnant during/after facilitated subcutaneous immunoglobulin (fSCIG) treatment are not well characterized. Materials & methods: This noninterventional, prospective, open-label, post authorization, pregnancy registry study assessed safety outcomes in mothers with primary immunodeficiency diseases who had ever received fSCIG before/during pregnancy and their infants (n = 7). Enrolled women received alternative treatment (arm 1: n = 2) or continued fSCIG (arm 2: n = 7) during pregnancy. Results: No treatment-related adverse events (AEs)/serious AEs (SAEs) were reported. 13 AEs occurred in mothers, including two SAEs (thrombocytopenia, pre-eclampsia; arm 2). A total of 17 AEs occurred in infants, including two SAEs (cleft lip, talipes calcaneovalgus; arm 2) with normal growth/development. Conclusion: Findings provide limited but useful safety data regarding women who received fSCIG before/during pregnancy and the growth/development of their infants. Clinical Trial registration: NCT02556775 ( ClinicalTrials.gov ); EUPAS5798